Mifepristone and Misoprostol for the Termination of Pregnancy up to 70 Days' Gestation in Kazakhstan

Completed

• Conditions: Complete Abortion
• Interventions: Drug: Mifepristone, misoprostol

• Registration Number: NCT02018796
• Lead Sponsor: Gynuity Health Projects

Brief Summary

The study will be conducted in 4 sites and will examine how a simplified outpatient medical abortion procedure using mifepristone and misoprostol, with the option to take mifepristone at a place of woman's choosing, works in Kazakhstan. The investigators intend to demonstrate the efficacy of oral administration of 200 mg mifepristone and sublingual administration of 600 µg misoprostol with gestations through 70 days, as well as the acceptability of this method. Research questions include:

1. What is the efficacy of regimen of 200 mg mifepristone, followed 24 to 48 hours later by 600 µg sublingual misoprostol and used in gestations of up to 70 days?

2. Is medical abortion procedure consisting of two visits acceptable to women in Kazakhstan?

3. Are the side effects associated with sublingual use of misoprostol acceptable to women?

4. When given a choice, do women prefer to take mifepristone in the clinic or at a place of their choosing?

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-12-10
• Study First Submitted QC: 2013-12-17
• Study First Posted: 2013-12-23
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-11
• Last Update Posted: 2015-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 290

Inclusion Criteria

• Have an intrauterine pregnancy consistent with gestational age less than 71 days;
• Be able to understand and willing to sign a consent form;
• Be eligible for medical abortion according to the clinician's assessment;
• Be able to return to the clinic and able to contact study staff or emergency medical services, if needed;
• Be willing to provide an address and/or telephone number for purposes of follow-up;
• Agree to comply with the study procedures and visit schedule.

Exclusion Criteria

• Confirmed or suspected ectopic pregnancy or undiagnosed adnexal mass;
• Chronic renal failure;
• Concurrent long-term corticosteroid therapy;
• History of allergy to mifepristone, or misoprostol or another prostaglandin;
• History of hemorrhagic disorders or concurrent anticoagulant therapy;
• History of inherited porphyrias;
• Intrauterine device in place (must be removed before mifepristone is administered).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Women seeking medical abortion	Mifepristone, misoprostol	Women with pregnancies less than 71 days gestation seeking medical abortion. Women who choose to participate in the study will be administered 200 mifepristone, followed 24 to 48 hours later by 600 mcg misoprostol.

Primary Outcome Measures

Name	Time	Method
Rate of successful abortion	2 weeks after mifepristone administration

Secondary Outcome Measures

Name	Time	Method
Satisfaction with method	2 weeks or up to 30 days after mifepristone administration

Trial Locations

Locations (4)

Almaty City Policlinic No. 9; 🇰🇿 Almaty, Kazakhstan

Consultation and Diagnostics Department of the City Maternity House; 🇰🇿 Astana, Kazakhstan

Consultation and Diagnostics Department of the Regional Perinatal Center No. 2; 🇰🇿 Astana, Kazakhstan

Almaty City Policlinic No. 19; 🇰🇿 Almaty, Kazakhstan